Current through Register Vol. 48, No. 9, September 27, 2024
1.
General.
(a) For purposes of this Regulation,
aquaculture encompasses the following:
(1)
Open-water and/or Land-based operations, other than shellfish seed hatchery
operations;
(2) Monoculture
(molluscan shellfish) or Polyculture (molluscan shellfish combined with
non-molluscan organisms) production.
(b) Any person operating a land based
aquaculture facility that grows or produces molluscan shellfish for sale shall
obtain the following from the Department prior to commencing operations or
harvesting shellfish for human consumption:
(1) An Aquaculture Facility Construction
Permit based upon criteria described in the facility's operational plan as
required by Section O.4(a); and
(2)
An Aquaculture Operating Permit based upon successfully meeting the
requirements of all applicable portions of this Regulation; and
(3) Certification as a processor, unless the
permitted aquaculturist provides the Department with prior notice that
harvested shellfish are to be delivered to a Shucker-Packer (SP), Repacker
(RP), Shellstock Shipper (SS), or Depuration Processor (DP) within the
State.
(c) Any person
operating an open water aquaculture facility that grows or produces molluscan
shellfish for sale shall obtain the following from the Department prior to
commencing operations or harvesting shellfish for human consumption:
(1) An Aquaculture Operating Permit based
upon successfully meeting the requirements of all applicable portions of this
Regulation; and
(2) Certification
as a processor, unless the permitted aquaculturist provides the Department with
prior notice that harvested shellfish are to be delivered to a Shucker-Packer
(SP), Repacker (RP), Shellstock Shipper (SS), or Depuration Processor (DP)
within the State.
(d)
Shellfish aquaculture shall be practiced only in strict compliance with the
specific provisions of the Aquaculture Permit.
(e) Applications for Aquaculture Permits must
contain a written operational plan detailing the scope and extent of the
operation.
(f) Water quality at any
site used for aquaculture shall meet the criteria for an approved,
conditionally approved, or restricted area classification provided, however,
this item shall not apply to shellfish seed operations when:
(1) The use of a prohibited growing area is
sanctioned for seed culture operations by the Department;
(2) Prior to relocation, seed cultured in any
prohibited area are demonstrated to the Department to have acceptable levels of
poisonous or deleterious substances;
(3) Seed cultured in prohibited growing areas
are relocated with Department authorization and cultured for a minimum of six
months in areas exhibiting approved area criteria; and
(4) Shellfish relocated in accordance with
this section shall not be harvested without Department authorization.
(g) Shellfish cultured in any
land-based system meeting the criteria for an approved area classification
throughout the culture period may be immediately marketed.
(h) Any shellfish raised in aquaculture shall
be subjected to relaying or depuration prior to direct marketing if the culture
area or facility is located in or using water that is in one of the following:
(1) A conditionally approved area
classification in a "closed" status; or
(2) A restricted area
classification.
(i) Only
drugs authorized by the United States Food and Drug Administration shall be
used for shellfish treatment.
(j)
Complete and accurate records shall be maintained for at least two years by the
aquaculturist and shall include the:
(1)
Source of shellfish, including seed;
(2) Dates of transplanting and harvest;
and
(3) Water source, its treatment
method, if necessary, and its quality in land based systems.
(k) Harvesting, processing,
storage, and transportation of shellfish shall comply with all other applicable
requirements of this Regulation.
2. Seed Source. Aquaculture Permit holders
shall provide the Department with documentation concerning the source of seed
shellstock.
3. Open Water
Operations. Open-water aquaculture operations shall comply with all applicable
requirements of this Regulation.
4.
Land-Based Operations. Applicants for land-based aquaculture permits shall
provide the following to the Department:
(a)
A written operational plan that shall include:
(1) A description of the design and
activities of the aquaculture facility;
(2) The specific site and boundaries in which
shellfish culture activities will be conducted;
(3) The types and locations of any
structures, including rafts, pens, cages, nets, tanks, ponds, or floats
utilized in the aquaculture operation;
(4) The species and source of shellfish,
including seed, to be cultured and harvested;
(5) If appropriate, the source and species of
other organisms to be cultured in any polyculture systems;
(6) Procedures to assure that no poisonous or
deleterious substances are introduced into the activities;
(7) A program of sanitation, maintenance, and
supervision to prevent contamination of the final shellfish products;
(8) A description of the water source,
including the details of any water treatment process or method, if
necessary;
(9) A program to
maintain water quality that includes collection of water samples for microbial
analysis, temperature and salinity monitoring, and analytical methods used. The
bacterial indicator monitored shall be the same as used for monitoring growing
areas;
(10) Collection of
information on the microbial and chemical quality of shellfish harvested from
the aquaculture site;
(11)
Collection of data concerning the quality of food produced for use in the
artificial harvest system;
(12)
Maintenance of the required records; and
(13) How shellstock will be harvested,
processed if applicable, and sold.
(b) Water Systems.
(1) Water disinfection will not be required
if shellfish are held at all times in continuous flow through systems that
utilize water from an approved growing area, or from a conditionally approved
area in the open status.
(2) Closed
or recirculating systems shall:
(a) Not
contaminate shellfish with residues that are not Generally Recognized As Safe
(GRAS) [see Title 21 CFR (April 1, 2007)]; and
(b) Utilize waters classified as approved,
conditionally approved or restricted; and
(c) Be maintained, at a minimum, at the
bacteriological quality of the restricted classification.
(3) If the water in the closed or
recirculating system is from water classified as conditionally approved, the
operational plan shall include a sampling schedule and shellfish shall not be
harvested until:
(a) a total of three water
samples have been collected from the system a minimum of three days apart over
a 14 day period; and
(b) fecal
coliform levels in each sample are not greater than fourteen (14) MPN per one
hundred (100) ml.
(c) Water
Quality.
(1) Shellstock held at all times in
waters meeting the criteria for an approved area may be used for direct
marketing.
(2) If the water in a
closed or recirculating system is from a source classified as conditionally
approved and in the open status, shellstock may be marketed directly if the
water quality meets a fecal coliform level of less than fourteen (14) MPN per
one hundred (100) ml. in each sample collected in the 14 days prior to
harvest.
(3) Shellstock in a closed
or recirculating system that does not meet the water quality requirements of
items O.4(c)(1) or O.4(c)(2) shall be relayed or depurated prior to direct
marketing.
5. Polyculture Activities. Aquaculture permit
applicants engaging in Polyculture activities shall include in an operational
plan provisions to:
(a) Provide information
concerning all sources and species of all organisms to be cultivated, cultured,
and harvested;
(b) Monitor for
human pathogens, unacceptable levels of animal drugs, and other poisonous or
deleterious substances that might be associated with polyculture activities;
and
(c) Subject all harvested
shellstock to relaying or depuration.
6. Mariculture Permit Areas. Operators of
shellfish mariculture permit areas permitted by the South Carolina Department
of Natural Resources shall provide the Department with a written operational
plan that shall include:
(a) A description of
activities associated with the operation including, but not limited to, the
operational requirements in C.2. (e)(2);
(b) The specific site and boundaries in which
shellfish culture activities will be conducted;
(c) The types and locations of any
structures, including rafts, pens, cages, nets, tanks, ponds, or floats
utilized in the aquaculture operation;
(d) The type and source of shellfish,
including seed, to be cultured and harvested;
(e) Documentation of the source of seed shell
stock
(f) Record keeping to
document compliance with the requirements described in item C.2. (e)(2) For
maricultured shellfish harvested during months that do require additional
temperature controls.